Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Positive diagnosis (anatomopathology) of tumor within 12 months

• Patient 18 years of age or older

• Patient with one of the following conditions:

‣ Desmoid fibromatosis of the abdominal wall operated on or under active surveillance

⁃ Stage I testicular seminoma (whether or not treated with carboplatin AUC7)

⁃ Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)

⁃ Operated GIST with low risk of relapse

⁃ Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated

⁃ Low-grade glioma, operated

⁃ Low-grade neuroendocrine tumor, treated by surgery alone

• Patient who has given consent to participate in the study

Locations
Other Locations
France
CHU Amiens
NOT_YET_RECRUITING
Amiens
Centre François Baclesse
NOT_YET_RECRUITING
Caen
Centre Oscar Lambret
RECRUITING
Lille
Contact Information
Primary
Laurence ROTSAERT
l-rotsaert@o-lambret.fr
0320295860 / 0320295918
Backup
Fanny BEN OUNE
f-benoune@o-lambret.fr
0320295918
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2029-10
Participants
Target number of participants: 88
Treatments
Experimental: Experimental
Telesurveillance by a nurse
Other: Control
On-site surveillance by a hospital physician
Sponsors
Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation, Canceropôle Nord Ouest
Leads: Centre Oscar Lambret

This content was sourced from clinicaltrials.gov